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Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy
Landen JW, Cohen S, Billing CB, Cronenberger C, Styren S, Burstein AH, Sattler C, Lee JH et al.. Alzheimer's & dementia (New York, N. Y.), 2017-05-10
Topic: Amyloid, tau and blood-test diagnosis
Introduction Multiple intravenous doses of ponezumab, an anti-amyloid antibody, were evaluated in subjects with mild-to-moderate Alzheimer's disease (AD). Methods In part A, 77 subjects were randomized to ponezumab 0.1, 0.5, or 1 mg/kg (75 treated) and 26 to placebo (24 treated). In part B, 63 subjects were randomized and treated with ponezumab 3 or 8.5 mg/kg and 32 with placebo. Subjects received 10 infusions over 18 months and were followed for 6 months thereafter. Results Ponezumab was generally safe and well tolerated. Most common adverse events were fall (16.7% ponezumab, 21.4% placebo), headache (13.8%, 21.4%), and cerebral microhemorrhage (13.8%, 19.6%). Plasma ponezumab increased dose-dependently with limited accumulation. Cerebrospinal fluid penetration was low. Plasma Aβ 1-x and Aβ 1-40 showed robust increases, but cerebrospinal fluid biomarkers showed no dose response. Ponezumab had no effects on cognitive/functional outcomes or brain volume. Conclusions Multiple-dose ponezumab was generally safe, but not efficacious, in mild-to-moderate AD.
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APA 7th
Landen, J. W., Cohen, S., Billing, C. B., Cronenberger, C., Styren, S., Burstein, A. H., et al. (2017). Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy. Alzheimer's & dementia (New York, N. Y.). https://doi.org/10.1016/j.trci.2017.04.003
Vancouver
Landen JW, Cohen S, Billing CB, Cronenberger C, Styren S, Burstein AH, et al. Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy. Alzheimer's & dementia (New York, N. Y.). 2017. doi:10.1016/j.trci.2017.04.003. PMID: 29067341.
BibTeX
@article{landen2017-29067341,
author = {Landen, J. W. and Cohen, S. and Billing, C. B. and Cronenberger, C. and Styren, S. and Burstein, A. H. and Sattler, C. and Lee, J. H. and others},
title = {{Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy}},
journal = {Alzheimer's \& dementia (New York, N. Y.)},
year = {2017},
doi = {10.1016/j.trci.2017.04.003},
pmid = {29067341},
url = {https://doi.org/10.1016/j.trci.2017.04.003}
}
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Key findings
- Results Ponezumab was generally safe and well tolerated.
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Study details
- Participants77
- Effect sizeor 8.5; 16.7%; 21.4%
- Evidence strengthHigh
How this study scored 64/100
Published in a leading specialty journal. Scored zero for study design because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multi-centre collaboration, so those were left out: it earned 37 of the 58 points we could judge it on, which is 64 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia (New York, N. Y.)) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 2 / 5 | 2017 — within 10 year(s) of the newest study here |
| Sample size | 1 / 4 | 77 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 29067341) |
| Free to read | 2 / 2 | Free to read |
| Points | 37 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 37 of the 58 points we could judge it on is 64 out of 100. |
| Total | 64 / 100 | — |
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